Peptide LibraryAfamelanotide dosage in published studies and labels
These are the doses used for Afamelanotide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Afamelanotide, sold in the research market as melanotan-1, has an FDA-approved human dosage - but not in the form it is sold as in the peptide market. The approved product, Scenesse, is a 16 mg controlled-release implant inserted subcutaneously above the anterior supra-iliac crest every 2 months, for erythropoietic protoporphyria. There is no approved injectable melanotan-1 and no approved dose for tanning.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 16 mg implant every 2 months |
| Route | Subcutaneous implant |
| Frequency | Every 2 months |
| Duration studied | Repeated during periods of sunlight exposure, per the label |
| Titration | None. The implant delivers a fixed 16 mg and is not titrated. |
| Evidence level | FDA Approved |
| Last reviewed | 2026-09-05 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label - Scenesse, erythropoietic protoporphyriaFDA-approved label · FDA prescribing information | Adults with a history of phototoxic reactions from erythropoietic protoporphyria | 16 mg implant | Subcutaneous implant, above the anterior supra-iliac crest, inserted by a trained professional | Every 2 months | Per label | Increase in pain-free light exposure | SCENESSE (afamelanotide) implant - FDA prescribing information, DailyMed |
| NCT01605136 - phase 3 confirmatory study, results postedClinical trial · Phase 3 randomised trial with posted results | Patients with erythropoietic protoporphyria (n=93) | Per trial protocol, implant | Subcutaneous implant | — | — | Pain-free sunlight exposure | NCT01605136 - Phase III Confirmatory Study in Erythropoietic Protoporphyria |
| NCT04053270 - multicentre phase 3, results postedClinical trial · Phase 3 trial with posted results | Patients with erythropoietic protoporphyria (n=100) | Per trial protocol, implant | Subcutaneous implant | — | — | Light tolerance and quality of life | NCT04053270 - Multicentre Phase III Erythropoietic Protoporphyria Study |
| NCT04525157 - phase 2, vitiligo with NB-UVB, results postedClinical trial · Phase 2 trial with posted results | Patients with vitiligo (n=21) | Per trial protocol, implant | Subcutaneous implant | — | — | Repigmentation alongside narrow-band UVB phototherapy | NCT04525157 - Afamelanotide and Narrow-Band Ultraviolet B Phototherapy in Vitiligo |
Where sources disagree
- The approved dose is a controlled-release implant placed by a trained professional, releasing 16 mg over several days. Melanotan-1 sold as a lyophilised vial for daily self-injection is a different dosage form entirely, and the implant's 16 mg does not translate into a daily injectable dose.
- Every approved and trialled use is a medical one - erythropoietic protoporphyria, and in trials vitiligo and solar urticaria - in which increased pigmentation is the mechanism, not the goal. There is no approved dose for cosmetic tanning.
- Melanotan-1 (afamelanotide) and melanotan II are different molecules with different pharmacology and different evidence. Melanotan II has no approved product; conflating the two transfers an approval that does not exist for it.